Kowid Ho, PhD

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for 4 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits de santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team. He was rapporteur for several quality guidelines for EMA (Process validation for biological, Biosimilar quality aspects, Monoclonal antibody). He also participated in the drafting of other European and International guidelines (EDQM HCP general chapter, EDQM rDNA monograph revision, ICH Q11, ICH Q12, WHO guideline for biotherapeutic protein).